An interventional study of Tortle Midliner in Intraventricular Hemorrhage of Prematurity, sponsored by Orlando Health, Inc.. Terminated at 1 site in United States. Open to participants aged Up to 31 Weeks. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by Orlando Health, Inc. · Not applicable, Interventional, and Prevention
The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs. of life to ensure maintenance of optimal midline positioning (Tortle group), will impact the IVH outcome as determined by a reduction in the rate and/or severity of IVH when compared to infants receiving the standard regimen of care (Control group).
Intraventricular hemorrhage (IVH) is defined as bleeding into the ventricles of the premature infant brain-the highest risk for the lowest gestational ages. IVH almost always occurs between birth and the first 72 hours of life. The four grades of IVH are based on the degree of bleeding; the greater the severity of the bleed, the more likely to have a poor outcome. Complications can include hydrocephalus, mental retardation, cerebral palsy and seizures. Neurologic sequelae can lead to death. Even for low grade bleeds the studies show the negative effects on cognitive scores and an increased incidence of learning disabilities. In addition, these same children often suffer from attention deficit disorder and other behavioral dysfunctions, which require intervention in order for the child to successfully integrate into school and society.
Since increased risk of IVH can be associated with changes of intracranial pressure, many medical protocols have established IVH bundles which are designed to help reduce fluctuations in intracranial pressure while managing the micro-preemie infant during the first few days of life.
The correlation between IVH and head positioning of the extremely low birth weight infants has made its way into research literature suggesting that venous obstruction can result from increased external pressure on the venous system when the micro-preemie infant has their head positioned to the side rather than maintaining a neutral position.
Therefore, the investigators are aiming to conduct a prospective randomized controlled trial in order to answer the research question: Does early use of the Tortle Midliner reduce the incidence and/or level of severity of intraventricular hemorrhage if used in infants born at ≤ 30 6/7 weeks and neutral position is maintained for the first 72 hours of life? The investigators hypothesize that the use of early consistent neutral positioning compared to the standard care (nested positioning) practiced in the Neonatal Intensive Care Unit (NICU) will reduce the risk of intraventricular hemorrhage in preterm infants born at ≤ 30 6/7 weeks and have a positive effect on the incidence and/or level of severity of intraventricular hemorrhage in this population.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 27 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Orlando Health, Inc. is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The use of the Tortle Midliner will be in addition to the NICU department process guidelines for positioning relevant to the gestational age of the subject. The Tortle Midliner will be applied no later than 3 hours following birth under the supervision of a study investigator. The size/fit and application of the device will be according to the manufacturer's guidelines. The neutral midline head position, supine or slightly side-lying, with a bed elevation between 15° and 30° will be maintained during the first 72 hours of life.
Device: Tortle Midliner
All clinical care for the control group will be within NICU department process guidelines relevant to the gestational age of the subject and as ordered by physician and/or ARNP providers. The neutral midline head position with the aid of nesting and/or rolls with a bed elevation between 15° and 30° will be maintained throughout position changes during the first 72 hours of life, which is standard practice. Caregivers will document the NICU integrated flowsheet and the Sunrise electronic record with interventions regarding positioning, handling, skin assessment etc. per standard practice requirements.
The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life.
Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants
Data analysis will include descriptive statistics with means and proportions. Comparative statistics will be used to compare IVH outcomes in the two groups. IVH outcome will be determined by a reduction in the incidence and/or severity of IVH. Any additional information on data points may be described in tables and/or graphs.
Time frame: IVH incidence and/or severity within the first week of life
Subjects were recruited in the NICU that met inclusion criteria
| Milestone | Tortle Midliner | Control Group |
|---|---|---|
| Started | 14 | 13 |
| Completed | 11 | 11 |
| Not completed | 3 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
Data analysis will include descriptive statistics with means and proportions. Comparative statistics will be used to compare IVH outcomes in the two groups. IVH outcome will be determined by a reduction in the incidence and/or severity of IVH. Any additional information on data points may be described in tables and/or graphs.
| Participants | Tortle Midliner | Control Group |
|---|---|---|
| Incidence of IVH | 3 | 3 |
| Incidence of no IVH | 8 | 8 |
Collected over Adverse events were followed from enrollment to discharge. Both groups meet criteria for a head ultrasound at 6-8 days of life. The results of the last head ultrasound and/or magnetic resonance imaging (MRI) of the brain before discharge will be collected. The duration from birth to discharge depends on the subject's medical needs. A duration of "Hospital Stay in Days" was collected as a variable. From enrollment to hospital discharge, the average timeframe was 72 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tortle Midliner | 0/14 (0%) | 1/14 (7.1%) | 0/14 (0%) |
| Control Group | 1/13 (7.7%) | 2/13 (15.4%) | 0/13 (0%) |
| Event | Tortle Midliner | Control Group |
|---|---|---|
| Hypotensive shock unresponsive to aggressive vasopressor therapyVascular disorders | 0/14 | 1/13 |
| Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 1/14 | 1/13 |
| Age, Categorical(Participants) | Tortle Midliner | Control Group | Total |
|---|---|---|---|
| <=18 years | 14 | 13 | 27 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Tortle Midliner | Control Group | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 8 | 9 | 17 |
| Race (NIH/OMB)(Participants) | Tortle Midliner | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 3 | 6 | 9 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Study data will be shared by publication
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orlando Health, Inc.